Cleared Traditional

FLEX D-4000

K951419 · U.S. Table, Inc. · Physical Medicine
Jun 1995
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K951419 is an FDA 510(k) clearance for the FLEX D-4000, a Table, Powered (Class I — General Controls, product code INQ), submitted by U.S. Table, Inc. (Glen Allen, US). The FDA issued a Cleared decision on June 30, 1995, 94 days after receiving the submission on March 28, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3760.

Submission Details

510(k) Number K951419 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1995
Decision Date June 30, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INQ — Table, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3760

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